None listed
Conditions
Brief summary
This is a phase 1 study utilizing two fixed dose formulations of ELAPR and a control, by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis. Healthy subjects will be recruited to the study. Following a screening period of up to 28 days, subjects who meet the entry requirements will be enrolled to one of two Cohorts, Cohort A or B and randomly assigned to receive treatment with one of two ELAPR formulations plus the control. All subjects will receive three treatments, 3 weeks apart.Subjects will attend the Woolcock Institute of Medical Research, Clinical Research Operations (WIMR) for all procedures. On Day 1, 22 and 43 all subjects will have the intradermal injections at WIMR. Subjects will then have safety observations for 60 minutes. Photography of injected sites will be performed before and 60 minutes following intradermal injections. Subjects will return to the WIMR on Day 8, 29 and 50, for evaluation. Each treatment will consist of 21 injections in total, each 5mm apart in a grid formation over a 3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each injection will consist of approximately 20ul of product delivered using a 30Gx1/4 inch needle. On Day 1, following the intradermal injections a needle point tattoo will be applied to the center of the implant site. The tattoo mark will assist in locating the implant sites and will be removed with the biopsy at Day 169 for cohort A and Day 85 for cohort B. Each subject will also receive Restylane (Registered Trademark) Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later. At each visit, subjects will be asked questions related to the status of implants, skin site texture and elasticity, skin reactions and any activities undertaken which may impact on the implant. The physical presence of the implants will be assessed by the investigator at each visit by palpation. Measurements of skin elasticity and skin thickness will be made using a Dermal Torque Meter (DTM) and skin calipers, respectively.
Interventions
Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 21 injections in total, each 5mm apart in a grid formation over a 3cm x 3cm area of the mid to deep dermis of the medial aspect of the upper arm. Each injection delivered by the treating doctor will consist of approximately 20ul of product delivered using a 30Gx1/4 inch needle. Each subject will receive ELAPR then Restylane (Registered Trademark) Vital Light (control) to the opposite arm following t
Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 21 injections in total, each 5mm apart in a grid formation over a 3cm x 3cm area of the mid to deep dermis of the medial aspect of the upper arm. Each injection delivered by the treating doctor will consist of approximately 20ul of product delivered using a 30Gx1/4 inch needle. Each subject will receive ELAPR then Restylane (Registered Trademark) Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. The concurrent treatment will be administered every three weeks on Day 1, 22 and 43.
Sponsors
Elastagen Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Good general health status Able to give informed consent
Exclusion criteria
Clinically significant abnormalities of haematology or biochemistry testing Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged APTT or PT Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents History of keloid formation Systemic corticosteroids within last 12 weeks Diabetes or other metabolic disorders that may interfere with the subject’s response to treatment in the opinion of the investigator Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication Pregnancy/lactation Previously received Tropoelastin A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine Sensitivity to Restylane (Registered Trademark) Vital light or Restylane products Use of any other investigational product on the intended implant site in the previous 12 months. Sensitivity to topical local anaesthetic cream (EMLA(Registered Trademark)) or have the following conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia, Glucose-6-phosphate dehydrogenase deficiency or mollusca contagiosa.
Outcome results
None listed